Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough

Phase 4

• Conditions: Cough, Acute
• Interventions: Drug: Bromelin; Drug: Placebo

• Registration Number: NCT01356693
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

Cough is the most bothersome symptom for patients with the common cold.

The objective of the study is to compare the phytotherapic "Bromelin", a compound preparation of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with placebo in reducing cough episodes in patients with the common cold.

Detailed Description

Common cold is very frequent and cough is one of the most troublesome symptoms. Over-the-counter medications are used by patients without prescription, many times with important side effects.

Bromelin, a compound made with honey and pineapple extract could offer cough symptomatic relief as a soothing agent.

This study aims to compare this compound with placebo in reducing cough in patients with common cold in an clinical trial designed in conformity to CONSORT guidelines.

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Study Start: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28
• Primary Completion: 2011-11
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• cough for less than 24 hours
• common cold symptoms : nasal obstruction, headache, myalgias, runny nose.

Exclusion Criteria

• declared chronic pulmonary diseases declared Nervous diseases declared Diabetes declared cardiac diseases known primary or secondary immunodeficiencies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active drug	Bromelin	Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.
Placebo	Placebo	Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.

Primary Outcome Measures

Name	Time	Method
Change in score in a cough evaluation questionnaire	before and 10 and 30 minutes after the dosing	A cough score based on number of coughing episodes and subjective 5 item cough score : no cough, mild, moderate, severe, very severe.

Secondary Outcome Measures

Name	Time	Method
Change in Occurrence of gastric symptoms	10 and 30 minutes	Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication

Trial Locations

Locations (1)

Hospital das Clínicas/UFPE; 🇧🇷 Recife, PE, Brazil